Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy (PALLM)

Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.

Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.

Study Overview

• Status: Recruiting
• Conditions: Myoma
• Intervention / Treatment: Device: Hyalobarrier

Detailed Description

Design:

Double-blind, randomized controlled pilot trial.

Participant:

• age between 18 and 45 years.
• intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
• absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy

Treatment:

Application of intrauterine Hyalobarrier® gel endo at time of surgery

Control:

No application of Hyalobarrier® gel endo

Follow up:

Second-look hysteroscopy after 3months

To blind all trial participants and gynaecologists doing second-look hysteroscopy, 10 ml of a sterile ultrasound gel will be applied into the vagina at the end of the procedure in all women regardless of their treatment allocation.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steffi Van Wessel, Dr.; Phone Number: 093320758; Email: studieco.vrouwenkliniek@uzgent.be
• Study Contact Backup: Name: Steven Weyers, Prof. dr.; Phone Number: 093320758; Email: studieco.vrouwenkliniek@uzgent.be

Study Locations

• Belgium
  • Ghent, Belgium
    • Recruiting
    • University Hospital Ghent
    • Contact: Steffi van Wessel, Dr.; Phone Number: 093320758
    • Contact: Steven Weyers, Prof. Dr.; Phone Number: 093320758
    • Contact: Steffi van Wessel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age between 18 and 45 years.
• intramurale and/or subserosal myoma (FIGO 3-6), and/or hybrid myoma (with a connection to the endometrium and serosa (FIGO 2-5), who are scheduled for laparoscopic / laparotomic myomectomy.
• absence of intra-uterine adhesions on preoperative diagnostic hysteroscopy

Exclusion Criteria:

• pregnancy.
• laparoscopic or laparotomic myomectomy in combination with an operative hysteroscopy.
• presence of endometritis.
• other antiadhesion methods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intrauterine gel application; Application of Hyalobarrier intrauterine after myomectomy.	Device: Hyalobarrier; Hyalobarrier is a viscous, transparent gel and is used as a preventive measure for post-operative adhesions in the abdominal and uterine cavity.; Other Names: anti-adhesive gel
No Intervention: no intra-uterine gel application; No application of Halobarrier intrauterine after myomectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesion formation postoperatief.	The presence of intra-uterine adhesions on a second look hysteroscopy.	3 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of adhesion formation	American Fertility Society classification (AFS) and classification of Valle and Sciarra are used to describe the severity.	3 months post surgery, at the time of the hysteroscopy.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Nordic Pharma SAS

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Myomectomy; Adhesion prevention; Intrauterine adhesions; Laparoscopic myomectomy; Postoperative adhesions; Laparotomic myomectomy; Antiadhesion method
• Additional Relevant MeSH Terms: Pathologic Processes; Cicatrix; Fibrosis; Tissue Adhesions
• Other Study ID Numbers: ONZ-2022-0355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No